Access to renal function information to improve pharmaceutical care in direct oral anticoagulant users: a cluster randomized trial protocol.
Source: PubMed, NCBI / U.S. National Library of Medicine
Direct oral anticoagulants (DOACs) are commonly prescribed for the management of thromboembolic diseases and are known to increase the risk of bleeding. Renal impairment is a risk factor for bleeding in DOACs users, making renal function access essential for community pharmacists during the prescription review and dispensing process. However, community pharmacists often have limited access to patients' renal function information. Giving Community Pharmacists full access to the renal function information could help to mitigate this preventable part of the risk of bleeding by optimizing DOACs choice and dosage, thereby helping to reduce the risk of bleeding events. This study aims to assess the impact of providing Community Pharmacists with access to patients' renal function information when dispensing DOACs on the occurrence of clinically relevant bleeding events three months after dispensing. A prospective, comparative, randomized, cluster, multicenter trial involving 96 community pharmacies, allocated into two groups: intervention (systematic access to renal function) and control (usual care). A total of 1920 patients will be included over a 24-month period and followed for 6 months. The primary endpoint is the occurrence of clinically relevant bleeding-major and nonmajor-occurring within three months after DOACs dispensing. Secondary endpoints include detail of pharmacist interventions and an assessment of the feasibility of providing renal function access to Community Phar
Abstract
Direct oral anticoagulants (DOACs) are commonly prescribed for the management of thromboembolic diseases and are known to increase the risk of bleeding. Renal impairment is a risk factor for bleeding in DOACs users, making renal function access essential for community pharmacists during the prescription review and dispensing process. However, community pharmacists often have limited access to patients' renal function information. Giving Community Pharmacists full access to the renal function information could help to mitigate this preventable part of the risk of bleeding by optimizing DOACs choice and dosage, thereby helping to reduce the risk of bleeding events. This study aims to assess the impact of providing Community Pharmacists with access to patients' renal function information when dispensing DOACs on the occurrence of clinically relevant bleeding events three months after dispensing. A prospective, comparative, randomized, cluster, multicenter trial involving 96 community pharmacies, allocated into two groups: intervention (systematic access to renal function) and control (usual care). A total of 1920 patients will be included over a 24-month period and followed for 6 months. The primary endpoint is the occurrence of clinically relevant bleeding-major and nonmajor-occurring within three months after DOACs dispensing. Secondary endpoints include detail of pharmacist interventions and an assessment of the feasibility of providing renal function access to Community Pharmacists. This study will assess the clinical impact of providing Community Pharmacists with access to renal function information. The findings have the potential to inform best practices and drive meaningful changes in ambulatory pharmaceutical care. The trial is registered with ClinicalTrials.gov: NCT06739603, December 17th, 2024. https://clinicaltrials.gov/study/NCT06739603?term=NCT06739603&rank=1.